Most drugs do not enter the brain through the blood stream due to the neuro-protective mechanism known as the blood brain barrier [The Merck Manual of Diagnosis and Therapy, 1999, 17th Ed., page 2562]. It has been shown that drugs administered as nose drops can enter the brain directly without entering the blood stream; however, none of the considered drug-targeting strategies for bypassing the blood brain barrier (BBB) have been proved sufficiently effective, and the dangerous side effects due to systemic overdose have been difficult to control [for example see Miyake M. M. and Bleier B. S.: Am. J. Rhinol. Allergy, 2015, 29(2), 124-7]. The direct path from the nasal cavity to the brain along the olfactory nerves was considered, for example, for intranasal delivery of insulin for the patients suffering from Alzheimer's disease, as intranasal insulin was shown to improve memory, attention, and functional status in patients in the early stages of Alzheimer's disease and those with mild cognitive impairment; however, any systemic insulin increase can have sever effects and must be, therefore, strictly prevented [Hanson L. R. and Frey W. H.: BMC Neurosci. 2008, 9 (Suppl 3): S5]. A need is felt for drug delivery systems for administering medicaments to the brain without dangerous changes of the systemic drug levels. Particularly, a need is felt for drug delivery systems for patients suffering from disorders associated with the central nervous system (CNS), wherein the disorders limit the capabilities of the patients to fully cooperate during the process of administering the drugs. Only in the U.S. there are more than five million people suffering from the Alzheimer's disease. It is therefore an object of the invention to provide a system for delivering medicaments to the brain of a human subject that suffers from a CNS disorder.
It is another object of the invention to provide a drug delivery system for administering a medicament to a subject while bypassing the BBB.
It is a further object of the invention to provide a device and a method for administering a medicament to a subject, while precluding dangerous systemic concentrations of said medicament.
It is a still further object of the invention to provide a device and a method for delivering a substance to the brain of a subject while precluding undesired increases of the substance concentrations in the blood or plasma of said subject.
It is also an object of the invention to provide a device and a method for administering a medicament to a subject suffering from a condition selected from neurologic disorders and psychiatric disorders, while precluding systemic overdose of said medicament.
It is still another object of the invention to provide a device and a method for administering a medicament to a subject with lowered level of alertness or reduced cognitive abilities.
It is further an object of the invention to provide a drug delivery system for administering a medicament to a subject comprising processing parameters associated with the level of alertness or the cognitive abilities of said subject.
Other objects and advantages of present invention will appear as description proceeds.